Aldurazyme

Medicinal product

(Invented) name

Aldurazyme

Active substance (s)

Laronidazė

Strength

100 V/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB05, Laronidase

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2003-06-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Laronidazė	100 V

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
24709	27352	1027352	flakonas	5 ml N1		Receptinis	EU/1/03/253/001	Netiekiama	-	-	No	-	-
24710	27353	1027353	flakonas	5 ml N10		Receptinis	EU/1/03/253/002	Netiekiama	-	-	No	-	-
24711	27354	1027354	flakonas	5 ml N25		Receptinis	EU/1/03/253/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-06-10	Registruotas